NDC 70518-2198 Neomycin And Polymyxin B Sulfates And Dexamethasone

Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone

NDC Product Code 70518-2198

NDC Code: 70518-2198

Proprietary Name: Neomycin And Polymyxin B Sulfates And Dexamethasone What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 70518 - Remedyrepack Inc.
    • 70518-2198 - Neomycin And Polymyxin B Sulfates And Dexamethasone

NDC 70518-2198-0

Package Description: 5 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Neomycin And Polymyxin B Sulfates And Dexamethasone with NDC 70518-2198 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Neomycin And Polymyxin B Sulfates And Dexamethasone is neomycin sulfate, polymyxin b sulfate and dexamethasone. The product's dosage form is suspension and is administered via ophthalmic form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Neomycin And Polymyxin B Sulfates And Dexamethasone Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NEOMYCIN SULFATE 3.5 mg/mL
  • POLYMYXIN B SULFATE 10000 [USP'U]/mL
  • DEXAMETHASONE 1 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)
  • Aminoglycosides - [CS]
  • Polymyxin-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Polymyxins - [CS]
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA062341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-10-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Neomycin And Polymyxin B Sulfates And Dexamethasone Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is:MW = 392.45Established name: dexamethasoneChemical name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17, 21-trihydroxy-16-methyl-, (11β, 16α)-.The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is:The structural formula for polymyxin B sulfate is:Each mL contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%.


Inactives: hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, benzalkonium chloride 0.004% (preservative).

Clinical Pharmacology

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.

Indications And Usage

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.Ocular corticosteroids are indicated in inflammatory conditions of the papebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:


Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species,


Neisseria species, and


Pseudomonas aeruginosa.


This product does not provide adequate coverage against:


Serratia marcesens and streptococci, including


Streptococcus pneumoniae.

Contraindications

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Warnings

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.Products containing neomycin sulfate may cause cutaneous sensitization.

General

The initial prescription and renewal of the medication order beyond 20 mL of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.As fungal infections of the cornea are particularly prone to develop coincidentally with long-term corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.If this product is used for 10 days or longer, intraocular pressure should be monitored (see


WARNINGS).


Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi.

Information For Patients

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of reach of children.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate. Treatment of cultured human lymphocytes


in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 μg/mL) tested. However, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.


Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.

Teratogenic Effects

Pregnancy Category CDexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose.In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.There are no adequate or well-controlled studies in pregnant women. Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the corticosteroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids.

Dosage And Administration

One to two drops in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in


PRECAUTIONS above.


FOR TOPICAL OPHTHALMIC USE ONLY.

How Supplied

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is supplied as a sterile ophthalmic suspension in a white, low density polyethylene DROP-TAINER* dispenser with a pink, polypropylene cap.5 mL in 8 mL bottle (


NDC 61314-630-06)


STORAGEStore upright at 8° - 27°C (46° - 80° F).Rx Only*DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.

Other

Revised: April 2008Printed in USADist. By:FALCON Pharmaceuticals, Ltd.Fort Worth, Texas 76134 USAMfd. By:ALCON LABORATORIES, INCFort Worth, Texas 76134 USA9003573-0408

* Please review the disclaimer below.

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